Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring - COGNIDES (Cognides)

Randomized Study Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring

The recovery of cognitive and psychomotor functions is best performed under anesthesia after desflurane when propofol in that obtaining a Aldrete score> 8/10 output of the allowing SSPI.

The principal objective is to compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane) using three tests (Stroop test, Digit Symbol Substitution task and a test of verbal memory (visual verbal learning test) made SSPI.

Study Overview

• Status: Completed
• Conditions: Orthopedic Surgery; Total Knee Replacement; Total Hip Prosthesis
• Intervention / Treatment: Drug: Intraoperative anesthetic strategy by Desflurane; Drug: Intraoperative anesthetic strategy by Propofol

Detailed Description

The day before surgery, patients sign the consent and will be randomized. Then 3 tests (Stroop test, Digit Symbol Substitution Task and visual verbal learning test) will be performed. No anxiolysis will be given to the patient. The anesthetic induction will be with IV propofol (2-3 mg / kg). The maintenance will anesthetic, desflurane by for a minimum alveolar concentration of between 2% and 6% or propofol for intravenous anesthesia user target controlled. In SSPI, the Aldrete score will be evaluated every 5min. Upon obtaining a Aldrete score> 8/10, the day before the tests will be carried out again

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Hopital Saint Antoine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years and ≤ 80 years
• ASA I, II
• General anesthesia provided
• Scheduled orthopedic surgery
• Duration of surgery between one and three hours
• Patient has given its written consent
• Patient receiving medical health insurance

Exclusion Criteria:

• MMS (Mini Mental State) ≤ 24
• Patient does not speak or read or do not understand the French
• Previous surgery within seven days
• Coronary insufficiency, renal, hepatic
• Chronic pulmonary disease
• Obesity (BMI> 35)
• Addiction
• Chronic alcoholism
• Hematocrit <25%
• Personal and family history of malignant hyperthermia
• Taking benzodiazepines or psychotropic within 24 hours preoperative
• Psychiatric pathology being
• Psychological or neurological disorder causing difficulties in understanding the study
• Chronic pain and / or taking analgesics 3.
• Pregnancy or breastfeeding
• Disorder of hemostasis: platelets <80,000 / mm3, PT <50% TCA> 1.5 times the control.
• Hypersensitivity to propofol or desflurane or any of the excipients
• Patients allergic to soy and peanuts
• History of liver disease, jaundice, unexplained fever, eosinophilia after administration of a halogenated anesthetic
• Hypersensitivity to egg lecithin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propofol; Intraoperative anesthetic strategy by Propofol versus Desflurane	Drug: Intraoperative anesthetic strategy by Desflurane; 2- Arm Desflurane Desflurane induction (2-3 mg / kg); Sufentanil (0.15 mg / kg IV); Atracurium (0.5 mg / kg IV)) Desflurane closed by maintenance target with minimal alveolar concentration (MAC) to adapt the circuit to obtain a figure 40
Experimental: Desflurane; Intraoperative anesthetic strategy by Desflurane versus Propofol	Drug: Intraoperative anesthetic strategy by Propofol; 1- Arm Propofol: Propofol TCI induction target between 2 and 6 mg / mL; Sufentanil (0.15 mg / kg intravenously (IV)); Atracurium (0.5 mg / kg IV) Maintenance mode by Propofol TCI target between 2 and 4 micrograms / mL tune to 40

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane)	Compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane), using three tests (Stroop test, Digit Symbol Substitution Task and test verbal memory (visual verbal learning test) made room post-interventional monitoring The primary endpoint will be the average score of three tests in room post-interventional monitoring (Stroop test, Digit Symbol Substitution Task, Visual Verbal Learning Test) scores expressed in standard deviation	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
proportion of patients with nausea and vomiting	1 day
Search intraoperative factors alterations in cognitive and psychomotor functions (number of red blood cells transfused, number of hypotensive episodes (≤ 80mmHg or MAP NOT ≤ 65mmHg)≥ 10 minutes).	1 day
Evaluate patient satisfaction on a visual analogue scale in room post-interventional monitoring	1 day
Evaluate postoperative pain in room post-interventional monitoring	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Cyrille Robert, PH, APHP

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 15, 2014

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 19, 2014
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Total knee replacement; Propofol; Desflurane; Orthopedic Surgery; Total hip prosthesis; Intraoperative anesthetic strategy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Hypnotics and Sedatives; Anesthetics, Inhalation; Anesthetics; Propofol; Desflurane
• Other Study ID Numbers: P120702; 2012-005270-61 (Other Identifier: eudraCTNumber)